PHS Human Subjects and Clinical Trials Information Form Walk-through

a walkthrough of the PHS human subjects and clinical trials information form NIH currently collects human subjects and clinical trials information across a number of application forms we are changing our data collection strategy for grant applications submitted to due dates on or after January 25 2018 we will continue to use the research and related other project information form to determine whether your application involves human subjects research and to collect information like exemption codes and human subject assurance numbers we will consolidate the remaining human subjects in clinical trials information currently collected on multiple forms into a new PHS human subjects in clinical trials information form this new form will allow us to collect detailed study level information for the protocols included in your application before you begin filling out the new form make sure you've completed the are in our other products information form the answers you provide on that form will try the data collection requirements for our new form as we explore this new form keep in mind that the look and feel of the form will be different based on whether you are using assist a system to system solution or workspace to prepare and submit your application for example buttons may have different labels or may be found in a different part of the screen but all the data fields and requirements remain the same regardless of these slight user interface differences now let's check out the new form if you answer no to the human subjects involved question on the other project information form then that answer is reflected at the top of our new form just below the pre-populated information is a section with the heading if no to human subjects you'll need to answer the question does the proposed research involve human specimens and/or data if you answer yes provide a justification for why you believe the application does not involve human subjects research and unless your funding opportunity announcement provides additional guidance for the form you're done with it simple if you answer yes to the human subjects involved question on the other project information form your answer is again reflected at the top of the form this time you'll go to the section of the form with the heading if yes to human subject and you'll need to provide at least one study record that study record maybe a full detailed study record or a delayed onset study record if you anticipate human subjects research will be done but definite plans for this involvement cannot be described until other aspects of your research are completed then you may meet our definition of delayed onset entering a delayed onset study is pretty easy simply provide a study title indicate whether one or more clinical trials are anticipated and attach a justification your justification must describe why detailed study information cannot be provided at the time of application and assurances that you will comply with all applicable policies such as the use of a single IRB board for domestic multi-site studies that will use the same protocol and a plan for the dissemination of NIH funded clinical trial information note delayed onset is not the same as delayed start where the information is known upfront but the work is not done in the initial budget period unlike delayed onset we expect a full study record for delayed start studies now let's look at a full study record study records are broken down into five sections the specific fields you'll need to complete will vary based on the specifics of your application I've marked the fields required for human subject studies with an HS icon and the additional fields you must complete if doing a clinical trial with a CT icon to help visualize requirements as we walk through the study record section 1 includes basic information and must be completed for all studies both those with and without clinical trials it includes a study title up to 600 characters which must be unique within the application exemption code information where the exemption code information provided on the other project information form was for the application as a whole this field asked about exemption code information at the study level a clinical trial questionnaire if you answer yes to all four questions the study will be considered a clinical trial requiring you to provide trial specific information and finally a clinical identifier often referred to as an NCT number this is an optional field since you aren't required to register in clinical until 21 days after your first participant is enrolled as we look at other sections of the study record you may notice our form in clinical have mini fields in common having a place on the form to collect the identifier positions us for future data exchange with clinical trials gov to reduce data entry and provide more consistent information between systems the additional sections in the study record are designed to lead you through our data collection requirements in a structured way providing specific fields for key information ensures each item has been given appropriate consideration it also ensures we have the data necessary and a consistent format for review and oversight of the study section 2 is study population characteristics you must complete this section for all studies unless exemption 4 applies you'll recognize the inclusion of women minorities and children attachment from our old forms and many of the other items in the section are structured fields for information previously collected within the protection of human subjects attachment the last item in this section is for inclusion reporting all studies must include at least one inclusion enrollment report we will no longer use the standalone PHS inclusion enrollment report form instead data collection for up to 20 inclusion enrollment reports has been folded into each study record for each inclusion enrollment report you'll need to indicate whether an existing data center resource will be used and whether the enrollment location type is domestic or foreign there are also a few optional fields in the report header including a text entry comment section and there are separate tables for planned and cumulative enrollment data section 3 is the protection and monitoring plans section it includes the protection of human subjects attachment previously found on the research plan form you'll want to read through our application guide instructions for this attachment since some of the information previously collected here is now collected on other named fields in the form all studies must provide a protection of human subjects attachment and answer the question regarding multi-site studies if you propose a multi-site study that will use the same proto to conduct non-exempt human subjects research at more than one domestic site you'll need to attach your plan describing how you would comply with the NIH policy on the use of single IRB for multi-site research the remaining fields in this section the data and safety monitoring plan attachment question about the use of a data safety monitoring board and the overall structure of the study team attachment are only required for studies involving clinical trials though other studies can include them if needed section four is the protocol synopsis you're only required to complete this section for study records involving independent clinical trials in fact you'll receive a system error if you try to submit information in this section for non clinical trial studies the protocol synopsis includes a brief summary of the objectives of the study including primary and secondary endpoints a series of fields related to study design including a description that type name and description for up to 20 interventions drop-down selections for primary purpose study phase intervention model and allocation and check boxes for masking information and the ability to provide the name type timeframe and description for at least one but up to 50 outcome measures we've also included a new dissemination plan attachment used to describe your plan for the dissemination of NIH funded clinical trial information you'll use this attachment to describe how you plan to meet the expectations of nih as new policies including the requirement to register and report your results in clinical trials gov the final sections section 5 is for other clinical trial related attachments which not surprisingly is only used in clinical trial study records and only when an attachment is specifically requested in the funding opportunity announcement to which you are applying we've seen how our new PHS human subjects in clinical trials information form consolidates human subjects information currently scattered across multiple agency forms expands clinical trial data collection to provide the appropriate level of information to improve oversight uses structured data fields to lead you through key requirements provides a consistent format for reviewers and staff to quickly find key information and aligns with clinical to position us for future data change between systems you'll find our updated application forms including our new human subjects in clinical trials form in the form Z application packages will be posting at the end of October forms the application packages must be used for applications submitted to due dates on or after January 25 2018 for more information about NIH s clinical trial changes visit our web site at Grant's that nih gov slash policy slash clinical trials HTM


  1. is there a fill-able version of the form? I can find the form but one that i can send to investigators to complete for the application since this form is embedded within the package. Our PI's don't actually complete the application package.

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